A Multicenter Randomized, Double-blind, Placebo-controlled Study of MP-435 in Combination With MTX in Patients With Rheumatoid Arthritis - Exploratory Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response
研究概览
简要总结
The purpose of this study is to determine the Efficacy, Safety, and Pharmacokinetics of MP-435 administered for 12 weeks in subjects with rheumatoid arthritis (RA) on stable doses of Methotrexate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987) for at least 6 months.
- •Subjects who inadequately response for stable dose of MTX.
排除标准
- •Patients with Class IV functional activity by the Steinbrocker's scale.
- •Patients who have received a biological agent in the past.
- •Patients who have other rheumatic diseases, or who have other diseases with joint symptoms.
- •Patients with severe or uncontrolled endocrine, psychiatric, cardiac, hematological, pulmonary, hepatic, kidney, gastrointestinal, or thyroid disease.
研究组 & 干预措施
1
dose1
干预措施: MP-435(dose1) + Methotrexate (Drug)
2
Placebo
干预措施: Placebo + Methotrexate (Drug)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response
时间窗: Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)
ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count \[TJC and SJC\] and in 3 to 5 assessments (participant's assessment of pain visual analog scale \[VAS\] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively\]; Health Assessment Questionnaire \[HAQ-DI\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; C-reactive protein\[CRP\]).
次要结局
- Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components(LOCF (Week 12 or discontinuation time))
- Percentage of Participants Achieving ACR 50 Response(Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time))
- Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components(LOCF (Week 12 or discontinuation time))
- Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response(Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time))